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New migraine drug shows promise for those caught in a Headache-Medication cycle

NCT ID NCT05452239

Disease control Sponsor: H. Lundbeck A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding eptinezumab to a brief educational program helps adults with both migraine and medication overuse headache. Over 600 participants received either eptinezumab or a placebo. The goal was to see if the drug could reduce the number of migraine days and the need for acute headache medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

608 people

The number who actually took part.

Started

Jul 2022

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit. * The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit. * The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit. * The participant has had an onset of migraine diagnosis at ≤50 years of age. Exclusion Criteria: * The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome). * The participant has a diagnosis of acute or active temporomandibular disorders. * The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). * The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit. * The participant has a history of clinically significant cardiovascular disease including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Headache Disorders, Secondary migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Medication overuse headache Migraine

Contacts and locations

Locations

  • AP-HP - Hopital Lariboisiere

    Paris, 75010, France

  • ASL 1 Abruzzo - PO Avezzano

    Avezzano, Abruzzo, 67051, Italy

  • Akershus Universitetssykehus

    Nordbyhagen, Akershus, 1474, Norway

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Assistance Publique Hopitaux de Marseille

    Marseille, Bouches-du-Rhône, 13385, France

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Aversi Clinic LTD

    Tbilisi, 0160, Georgia

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134, Italy

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2

    Naples, Campania, 80138, Italy

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2

    Palermo, 90127, Italy

  • Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

    Perugia, Umbria, 06129, Italy

  • Azienda Ospedaliero Universitaria Consorziale Policlinico

    Bari, Apulia, 70124, Italy

  • Azienda Ospedaliero Universitaria Di Modena Policlinico

    Modena, 41100, Italy

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, Córdoba, 14004, Spain

  • CHRU Nantes

    Saint-Herblain, Loire-Atlantique, 44800, France

  • CHU de Nice

    Nice, Alpes-Maritimes, 06000, France

  • CTC Clinical Trial Consultants AB

    Solna, Stockholm County, 176 64, Sweden

  • Centre Hospitalier Annecy Genevois - Site d'Annecy

    Pringy, Haute-Savoie, 74374, France

  • Centre Hospitalier Universitaire de Clermont Ferrand -58 Rue Montalembert

    Clermont-Ferrand, Puy-de-Dôme, 63003, France

  • Centre Hospitalier Universitaire de Saint Etienne

    Saint-Priest-en-Jarez, Pays de la Loire Region, 42055, France

  • Clinical Research of Central Florida - ClinEdge - PPDS

    Winter Haven, Florida, 33880-3053, United States

  • Clinvest - National Ave - Headlands - PPDS

    Springfield, Missouri, 65807-6012, United States

  • Danish Headache Center

    Glostrup Municipality, Capital, 2600, Denmark

  • Dent Neurologic Institute - Amherst

    Amherst, New York, 14226-1727, United States

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy, 20133, Italy

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    Rome, Lazio, 00168, Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Rome, Lazio, 00128, Italy

  • Groupe Hospitalier Paris Saint Joseph

    Paris, 75014, France

  • Hallands Sjukhus Halmstad

    Halmstad, Halland County, 301 85, Sweden

  • Haukeland Universitetssykehus

    Bergen, Hordaland, 5021, Norway

  • Headache Center - Montefiore Medical Center - BRANY - PPDS

    The Bronx, New York, 10461-2732, United States

  • Hospices Civils de Lyon - Hôpital Pierre Wertheimer

    Bron, Rhône, 69500, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47010, Spain

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010, Spain

  • Hospital Puerta del Mar

    Cadiz, Cádiz, 11009, Spain

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid, 28050, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013, Spain

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Hôpital Pierre-Paul Riquet

    Toulouse, Haute-Garonne, 31000, France

  • Hôpital Roger Salengro

    Lille, Nord, 59000, France

  • IRCCS Istituto delle Scienze Neurologiche - Largo B. Nigrisoli

    Bologna, Emilia-Romagna, 40139, Italy

  • IRCCS San Raffaele

    Rome, Lazio, 00163, Italy

  • Karolinska Universitetssjukhuset Huddinge

    Huddinge, Stockholm County, 141 52, Sweden

  • Klinikverbund Südwest - Kliniken Sindelfingen

    Sindelfingen, Baden-Wurttemberg, 71065, Germany

  • Kopfschmerzzentrum Frankfurt

    Frankfurt am Main, Hesse, 65929, Germany

  • Legacy Clinical Solutions: Tandem Clinical Research LLC - Medical Center - Marrero - ClinEdge - PPDS

    Marrero, Louisiana, 70072-3083, United States

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333 ZA, Netherlands

  • Ltd Israel-Georgia Medical Research Clinic Helsicore

    Tbilisi, 0112, Georgia

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center-Gobronidze 10

    Tbilisi, 0101, Georgia

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101, Australia

  • MediClubGeorgia Ltd

    Tbilisi, 0160, Georgia

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186, Georgia

  • Oslo Universitetssykehus

    Oslo, Norway

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, Lombardy, 20127, Italy

  • Pineo Medical Ecosystem

    Tbilisi, 0114, Georgia

  • Praxis fuer Neurologie, Spezielle Schmerztherapie und Psychotherapie

    Essen, North Rhine-Westphalia, 45133, Germany

  • Royal Melbourne Hospital

    Parkville, Victoria, 3052, Australia

  • S. Khechinashvili University Clinic, Ltd.

    Tbilisi, 0179, Georgia

  • Skaneuro Privatmottagning

    Lund, Skåne County, 227 33, Sweden

  • Southern Neurology

    Kogarah, New South Wales, 2217, Australia

  • St. Olav's University Hospital

    Trondheim, Sør-Trøndelag, 7006, Norway

  • Studienzentrum Nord-West

    Westerstede, Lower Saxony, 26655, Germany

  • Sydvestjysk Sygehus Esbjerg

    Esbjerg, 6700, Denmark

  • Texas Center for Drug Development, Inc

    Houston, Texas, 77081, United States

  • Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101

    Jena, Thuringia, 07747, Germany

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, Saxony, 01307, Germany

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitätsmedizin Greifswald

    Greifswald, 17475, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.